[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Rules and Regulations]
[Page 32983-32985]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn03-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. 02N-0288]
Medical Devices; Designation of Special Control for Eight
Surgical Suture Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to amend the classification regulations for eight surgical suture
devices previously reclassified into class II to specify a special
control for those devices. The special control is an FDA guidance
document entitled ``Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA'' that identifies
performance, testing, and labeling recommendations for the devices.
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the guidance document that will serve as the special
control. FDA is taking these actions on its own initiative because it
believes they are necessary to provide reasonable assurance of the
safety and effectiveness of surgical suture devices. These actions are
being taken under the Federal Food, Drug, and Cosmetic Act (the act).
DATES: This rule is effective July 3, 2003.
FOR FURTHER INFORMATION CONTACT: Anthony D. Watson, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 164.
SUPPLEMENTARY INFORMATION:
I. Background
The act (21 U.S.C. 301 et seq.), as amended by the Medical Device
Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe
Medical Devices Act of 1990 (SMDA) (Public Law 101-629), the Food and
Drug Administration Modernization Act (FDAMA) (Public Law 105-115), and
the Medical Device User Fee and Modernization Act (MDUFMA) (Public Law
107-250) established a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the act (21
U.S.C. 360c) established three categories (classes) of devices,
depending on the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
Under the 1976 amendments, class II devices were defined as those
devices for which there is insufficient information to show that
general controls themselves will assure safety and effectiveness, but
for which there is sufficient information to establish performance
standards to provide such assurance.
SMDA broadened the definition of class II devices to mean those
devices for which the general controls by themselves are insufficient
to provide reasonable assurance of safety and effectiveness, but for
which there is sufficient information to establish special controls to
provide such assurance, including performance standards, postmarket
surveillance, patient registries, development and dissemination of
guidelines, recommendations, and any other appropriate actions the
agency deems necessary (section 513(a)(1)(B) of the act).
The 1976 amendments also broadened the definition of ``device'' in
201(h) of the act (21 U.S.C. 321(h)) to include certain articles that
were once regulated as drugs. Under the 1976 amendments, Congress
classified into class III all transitional devices, i.e., those devices
previously regulated as new drugs, including surgical sutures.
II. Regulatory History of the Devices
In the Federal Register of December 16, 1977 (42 FR 63472), FDA
published a notice that identified sutures as class III devices under
the transitional provisions of the act. Section 520(l)(2) of the act
(21 U.S.C. 360j(l)(2)) provides that the manufacturer or importer of a
device classified in class III under the transitional provisions may
file a petition for reclassification of the device into class I or
class II. Procedures for filing and review of classification petitions
are set forth in Sec. 860.136 (21 CFR 860.136).
In accordance with section 520(l)(2) of the act and Sec. 860.136,
and after consulting with members of the General and Plastic Surgery
Devices Panel, FDA reclassified surgical suture devices from class III
to class II as follows:
1. Absorbable poly(glycolide/L-lactide) surgical suture (21 CFR
878.4493), reclassification order (letter) dated September 14, 1989;
2. Stainless steel suture (21 CFR 878.4495), reclassification order
(letter) dated July 30, 1986;
3. Absorbable surgical gut suture (21 CFR 878.4830),
reclassification order (letter) dated September 19, 1988;
4. Nonabsorbable poly(ethylene terephthalate) surgical suture (21
CFR 878.5000), reclassification order (letter) dated July 5, 1990;
5. Nonabsorbable polypropylene surgical suture (21 CFR 878.5010),
reclassification order (letter) dated July 5, 1990;
6. Nonabsorbable polyamide surgical suture (21 CFR 878.5020),
reclassification order (letter) dated February 15, 1990;
7. Natural nonabsorbable silk surgical suture (21 CFR 878.5030),
reclassification order (letter) dated November 9, 1990; and
8. Nonabsorbable expanded polytetrafluoroethylene surgical suture
(21 CFR 878.5035), reclassification order (letter) dated September 9,
1999.
In the Federal Register of December 19, 2002 (67 FR 77678), FDA
published a proposed rule to designate a special control for eight
surgical suture devices already classified into class II. FDA proposed
that surgical suture devices would remain in class II, but would be
subject to a special control. The proposed rule identified the special
control as an FDA guidance document entitled ``Class II Special
Controls Guidance Document: Surgical Sutures; Guidance for Industry and
FDA.'' In the same edition of the Federal Register, FDA announced the
availability of the draft guidance that, when final, was intended to
serve as a special control (67 FR 77797). FDA invited interested
persons to comment on the proposed rule and on the proposed special
control guidance document by March 19, 2003.
III. FDA's Conclusion
FDA received no comments on the proposed rule or on the guidance
document proposed as the special control. Therefore, under the SMDA
authority, FDA is amending the classification regulations for eight
surgical suture devices previously reclassified into class II, to
designate a special control for those devices. The special control
capable of providing reasonable assurance of safety and effectiveness
for these devices is a guidance document entitled ``Class II Special
Controls Guidance Document: Surgical Sutures; Guidance for Industry and
FDA'' that identifies performance,
[[Page 32984]]
testing, and labeling recommendations for the devices. Elsewhere in
this issue of the Federal Register, FDA is announcing the availability
of the special control guidance.
Following the effective date of this final rule, any firm
submitting a 510(k) premarket notification for a new surgical suture
will need to address the recommendations in the special control
guidance. However, the firm need only show that its device is as safe
and effective as a device that meets guidance recommendations. The firm
may use alternative approaches if those approaches address the
performance, testing, and labeling issues identified in the guidance.
IV. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this final
rule is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
FDA has examined the impact of the final rule under Executive Order
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the rule is
not a significant regulatory action as defined by the Executive order
and so is not subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The special controls guidance document does not
impose any new burdens on manufacturers of these devices. FDA has
granted 201 substantial equivalence orders from 95 manufacturers of
these devices in the last 10 years. The guidance document is based upon
the review of the information submitted in these premarket
notifications. Based on the review of the premarket notifications, FDA
believes that manufacturers presently marketing these devices are in
conformance with the guidance document and they will not need to take
any further action. The guidance document merely assures that, in the
future, devices of these generic types will be at least as safe and
effective as the presently marketed devices. These devices are already
subject to premarket notification and labeling requirements. The
guidance document advises manufacturers on appropriate means of
complying with these requirements.
The consensus standards in the guidance were recognized under
section 514(c) of the act (21 U.S.C. 360d(c)) for the purpose of
demonstrating certain aspects of substantial equivalency. The
manufacturer may provide a declaration of conformity to a recognized
standard to meet a premarket notification requirement. Ordinarily, this
will provide a simplified method of meeting the requirement. The
manufacturer may choose to submit other data or information to meet the
requirement. The guidance document sets out options that the
manufacturer has in this respect.
For the foregoing reasons, the agency certifies that this rule will
not have a significant economic impact on a substantial number of small
entities. In addition, this rule will not impose costs of $100 million
or more on either the private sector or State, local, and tribal
governments in the aggregate, and therefore a summary statement or
analysis under section 202(a) of the Unfunded Mandates Reform Act of
1995 is not required.
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.
List of Subjects in 21 CFR Part 878
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Section 878.4493 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4493 Absorbable poly(glycolide/L-lactide) surgical suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
0
3. Section 878.4495 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4495 Stainless steel suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
0
4. Section 878.4830 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4830 Absorbable surgical gut suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
0
5. Section 878.5000 is amended by revising paragraph (b) to read as
follows:
Sec. 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical
suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
0
6. Section 878.5010 is amended by revising paragraph (b) to read as
follows:
[[Page 32985]]
Sec. 878.5010 Nonabsorbable polypropylene surgical suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
0
7. Section 878.5020 is amended by revising paragraph (b) to read as
follows:
Sec. 878.5020 Nonabsorbable polyamide surgical suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
0
8. Section 878.5030 is amended by revising paragraph (b) to read as
follows:
Sec. 878.5030 Natural nonabsorbable silk surgical suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
0
9. Section 878.5035 is amended by revising paragraph (b) to read as
follows:
Sec. 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical
suture.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Surgical Sutures; Guidance for Industry and FDA.'' See Sec.
878.1(e) for the availability of this guidance document.
Dated: May 20, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-13825 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S